Senior Director, Risk Management
MSCCN - Summit, NJ
Apply NowJob Description
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: /working-with-us . Position Summary: Reporting to the Executive Director, Predictive Quality. Ensure consistent Global Leadership and support for key Quality Risk Management (QRM) processes within the GxPs (GMP, GDP, GLP, Medical Devices, Cell Therapy, GCP & GVP) across the Product Lifecycle. Accountable to Identify and drive QRM process optimization, integration, adoption and continuous improvement through procedural writing, training, meeting management, and trend analysis of QRM data. Works cross-functionally to develop performance improvement initiatives throughout the organization. Key Responsibilities: Provide strategic leadership for the establishment of a robust QRM program including defining and implementing a governance program. Work in close collaboration with Global Process Owner and QRM team to ensure Level 2 processes remain in a state of control and are effective/efficient. Designs and leads implementation of a comprehensive quality risk management program including developing and monitoring quality metrics and ensuring all regulatory requirements are met. Identify and track progress against key project milestones partnering with applicable business, quality and other enabling functions and any external providers to ensure overall project success. Provides strategic oversight for process monitoring/adoption and GxP risk profiles through data collection, analysis, trending and reporting of QRM dashboards, and following up on non-compliances, risk trends, and continuous improvement. Support the design, development, testing and roll out of IT systems supporting QRM processes and data analytics. Work effectively across the GxP Quality Management Systems network, engaging with broader Process Owner network and functional/site SMEs in order meet project milestones, and continuously improvement process adoption and enhancements. Leads and participates in regulatory surveillance and Pharma Industry networking/benchmarking initiatives with peers internally and externally to ensure awareness of current regulations/guidance that impact QRM processes and identify/execute procedural enhancements as required. Provides strategic input for the design of the QRM training strategy and enables deployment in partnership with the S&BE Learning and Operational Excellence team who will own execution of training across GQ. Leads QRM Community of Practices (CoPs) including sharing best practices, training/coaching and regular communication of QRM strategies/risk dashboards and process improvements. Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses, critical function in supporting the sites. Ensures compliance with regulatory requirements relating to investigation, company policies and procedures. Qualifications & Experience: Bachelor's degree in Nature Science, Pharmacy, or other Healthcare-related field. A minimum of twelve (12) years of experience in in the BioPharma/Pharmaceutical industry with cross-functional experience in one or more areas (i.e. research, clinical, pharmacovigilance, analytical, quality, engineering, manufacturing, CMC, regulatory or IT) with at least three (3) years' experience working in the QRM field. Thorough understanding of company policies and regulatory requirements and guidelines, and their relation to the management and documentation of product quality and serious breach investigations. Good understanding of global regulatory agencies and compliance requirements. Expert-level knowledge and experience using data to drive understanding, decisions, and recommendations. Familiar with electronic quality system tools. Strong program and project management experience with proven track-record of several years managing cross-functional programs and ability to manage multiple, simultaneous projects, preferably in Quality. Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities. Experience with partner management. Demonstrated influential leadership expertise and experience with senior level interactions and influence with GxP functional areas and Global Quality. Demonstrated Enterprise mindset to be able to think and act across functions and divisions. Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. Demonstrated people management experience. Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.) Strong and demonstrated strategic thinking capability with strong project management focus and ability to focus on execution of strategic decisions while balance conflicting priorities. Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet high quality requirements with tight deadlines. Demonstrated change agility in anticipating and leading others through change and ambiguity. Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising. #LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as 'Transforming patients' lives through scienceâ„¢ ', every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit / ( eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Company: Bristol Myers Squibb Req Number: R1574623 Updated: 2023-11-14 20:05:36.791 UTC Location: Summit,New Jersey Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Created: 2024-05-04